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510(k) K802555

COTTRELL 90/90 BACKTRAC by Lossing Orthopedic, Inc. — Product Code HST

K802555 is an FDA 510(k) premarket notification submitted by Lossing Orthopedic, Inc. for the device "COTTRELL 90/90 BACKTRAC". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Lossing Orthopedic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

Other clearances by Lossing Orthopedic, Inc.

  • K900475 — DISTRAC(TM) TABLE (May 24, 1990)
  • K864152 — BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE (February 5, 1987)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K843581 — PROM NAID (December 11, 1984)
  • K840551 — MOBILIZER (March 23, 1984)
  • K823236 — BACK ON TRACK INVERSION THERAPY & EXER (January 21, 1983)
  • K813017 — NECKTRAC (November 25, 1981)

Other clearances for product code HST

  • K162702 — Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Dec (December 30, 2016)
  • K110858 — LO-BAK TRAX (August 2, 2011)
  • K984190 — BACK-ON-TRAC, MODEL 101BOT (March 15, 1999)
  • K872121 — K AND D HOME TRACT (August 12, 1987)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)
  • K870125 — EXTREMITY ELEVATOR (February 4, 1987)
  • K870102 — TUPPER TROLLEY (February 3, 1987)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)

FDA data resources